Clinical Study Schedule of Activities
1.0.0 - trial-use

Clinical Study Schedule of Activities, published by HL7 International - Biomedical Research & Regulation Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/Vulcan-schedule-ig/ and changes regularly. See the Directory of published versions

## Example ResearchStudy: H2Q-MC-LZZT Research Study

Generated Narrative: ResearchStudy

Resource ResearchStudy "H2Q-MC-LZZT-ResearchStudy"

Profile: ResearchStudySoa

identifier: id: H2Q-MC-LZZT (use: USUAL), id: NCTA12313212 (use: OFFICIAL), id: 60809

title: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease

protocol: PlanDefinition/H2Q-MC-LZZT-ProtocolDesign

status: completed

primaryPurposeType: Treatment (ResearchStudyPrimaryPurposeType#treatment)

phase: Phase 3 (ResearchStudyPhase#phase-3)

category: Interventional Study (ncimeta.nci.nih.gov#C98388), Randomized Clinical Trial (ncimeta.nci.nih.gov#C15417), Double Blind Study (ncimeta.nci.nih.gov#C15228), Placebo Control (ncimeta.nci.nih.gov#C49648), Parallel Study (ncimeta.nci.nih.gov#C82639)

focus: Xanomeline (ncimeta.nci.nih.gov#C152926), Transdermal Patch Dosage Form (ncimeta.nci.nih.gov#C149996), PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease ()

condition: Alzheimer's Disease (Disorder) (SNOMED CT#26929004)

contact: Bob James, Ph.D.: ph: 555-555-5555(WORK)

### RelatedArtifacts

- | Type | Label | Display | Citation | Url
* | documentation | Arch Neurol.1997;54(4):465-473 | Arch Neurol.1997;54(4):465-473 | Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022 |
* | documentation | Protocol H2Q-MC-LZZT(c) |  |  | https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf

keyword: Selective M1 muscarinic agonists (Medical Subject Headings#D018721), Alzheimer Disease (Medical Subject Headings#D000544), Selective M1 muscarinic agonists (Medical Subject Headings#D018721)

description: ## Xanomeline (LY246708) ### Protocol H2Q-MC-LZZT(c) Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease

sponsor: Organization/EliLillyAndCompany

principalInvestigator: Practitioner/SamGetWell " HOME"

reasonStopped: Accrual Goal Met (ResearchStudyReasonStopped#accrual-goal-met)

> arm

> name: Placebo

> type: C49648 (ncimeta.nci.nih.gov#C49648)

> description: Placebo arm

> arm

> name: Low-dose xanomeline arm

> type: C174266 (ncimeta.nci.nih.gov#C174266)

> description: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)

> arm

> name: High-dose xanomeline arm

> type: C174266 (ncimeta.nci.nih.gov#C174266)

> description: High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)

> objective

> name: To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).

> type: Primary (ResearchStudyObjectiveType#primary)

> objective

> name: To document the safety profile of the xanomeline TTS.

> type: Primary (ResearchStudyObjectiveType#primary)

> objective

> name: To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.

> type: Secondary (ResearchStudyObjectiveType#secondary)

> objective

> name: To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.

> type: Secondary (ResearchStudyObjectiveType#secondary)

> objective

> name: To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.

> type: Secondary (ResearchStudyObjectiveType#secondary)

> objective

> name: To assess the treatment response as a function of Apo E genotype.

> type: Secondary (ResearchStudyObjectiveType#secondary)